When we wash our hair, moisturize our skin, or apply our mascara in the morning, most of us take it for granted that the health and beauty items we use on a daily basis are safe—after all, doesn’t the FDA approve cosmetics?
Actually, the answer is no. Although the Food & Drug Administration can regulate cosmetics to a degree, it cannot require approval to ensure that products marketed as cosmetics are safe or effective before they hit store shelves—a fact that has gained attention lately as some popular beauty products have been linked to adverse reactions. One of the most recent involved tens of thousands of customers complaining of rashes and hair falling out after using Wen hair care products from celebrity-endorsed stylist Chaz Dean.
The largely self-regulated cosmetics industry places a considerable burden on the consumer to investigate which cosmetics and personal care products are suitable for them—a situation where “let the buyer beware” truly applies.
What products qualify as “cosmetics” and why aren’t they more closely controlled by the FDA?
The FDA requires companies that manufacture and sell medications to follow certain guidelines for testing to ensure drug safety and efficacy, and ingredients must gain pre-market approval before a product can be sold to the public. “Drugs” are defined by the FDA as “products intended to affect the structure or function of the body”—in other words, products that that are intended to treat, cure or prevent a condition. This includes over-the-counter items like Tylenol, Benadryl, and sunscreen as well as prescription-only products like Prednisone, Latisse, or BOTOX.
On the other hand, cosmetics are defined as products that are made “for cleansing, beautifying, promoting attractiveness, or altering the appearance” but do not have a therapeutic use and do not affect the body’s function. For example, a concealer is considered a cosmetic because it can cover up age spots and wrinkles but doesn’t do anything to actually lessen these signs of aging (in contrast, BOTOX is considered a drug because it blocks nerve impulses to relax wrinkles).
“Personal care products” are not defined as a unique class by the FDA and can contain products that qualify as drugs, cosmetics, or both. Dandruff shampoos, medicated lip balm, and toothpaste are examples—the pharmaceutical ingredients in these products are subject to pre-approval by the FDA.
Cosmetics are FDA regulated, but not FDA approved
Why does the FDA require drugs to be approved before going to market, but not cosmetics? In short, because they do not currently have the authority to do so. The Federal Food, Drug & Cosmetic Act of 1938, the legislation that establishes the FDA’s duties, allows the FDA to regulate cosmetics labeling and inspect cosmetic manufacturing facilities to ensure that they are using safe production practices and not making false product claims. In doing so, the FDA requires companies to print a complete and accurate list of ingredients. However, the cosmetics companies themselves, not the FDA, are responsible for:
- Testing their products to ensure they are effective and safe for all consumers
- Keeping and disclosing records of consumer complaints of adverse events (consumers can directly report adverse events to the FDA, but complaints made to the company do not have to be reported to the FDA)
- Issuing recalls for products that may put consumers at risk
What are the implications of this lack of oversight?
For the most part, health and beauty products on drug and department store shelves are safe—companies have a reputation to uphold and want people to enjoy their products, after all. The problem is that there are poor protections in place should a product turn out to be unsafe. For example:
- Companies have no obligation to report outcomes of product testing or incidences of adverse effects caused by their product to the FDA.
- Unless it can be proved that a product is contaminated or mislabeled, consumers have little legal recourse in the event of an adverse reaction. In other words, as long as the product contains what is printed on the label and provides instructions for use, the company has acted legally, even if an ingredient proves to be harmful to certain users.
- Companies can continue to sell products regardless of how many customer complaints they have received about adverse reactions.
In short, the largely self-regulated cosmetics industry places a considerable burden on the consumer to investigate which ingredients may not be suitable for them when choosing personal care products. It is a situation in which the old adage “let the buyer beware” truly applies.
Could the Personal Care Products Safety Act be the right solution?
The cosmetics language in the Federal Food, Drug & Cosmetics Act has not been updated since its inception in 1938, and several members of Congress and consumer advocacy groups say the need for heightened regulation of the cosmetics industry is long overdue. They argue that we know so much more about the effects of certain chemicals on human health than we did in the 1930s, and that current law does not reflect this knowledge.
If made law, the Personal Care Products Safety Act would subject cosmetics to many of the same oversights as pharmaceuticals, including reporting of adverse events and mandatory product recalls.
A bill currently under consideration in the Senate, called the Personal Care Products Safety Act, sponsored by Senators Dianne Feinstein and Susan Collins, moves to update existing legislation and subject cosmetics to many of the same oversights as pharmaceuticals. Key changes proposed in the bill include:
- Cosmetics companies would have to register their products with the FDA
- Companies would be required to report serious adverse events, and the FDA would generate a publicly available annual report on adverse events for each product
- 5 potentially toxic chemicals, such as formaldehyde and lead acetate, which currently appear in many health and beauty products, would be subject to immediate review
- The FDA would have the authority to recall potentially unsafe products
A number of large cosmetics companies, including Proctor & Gamble and Estee Lauder, as well as consumer advocacy groups such as the Environmental Working Group, support the bill, while others have expressed opposition, saying that the stringency of the proposed legislation would unfairly penalize smaller independent cosmetics manufacturers.
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